nasal

Product NDC: 42507-388
11-digit product format: 425070388
Labeler code: 42507
Product ID: 42507-388_ac3c1c7a-c771-41c8-81bc-1d71bfe48250
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: HyVee Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-05-13
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-388-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-388-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-388-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-388-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-388-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-388-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42507-388-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42507-388-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42507-388-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-388-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-388-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-388-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: nasal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8a48a00-3533-4c4d-94e1-8a6c6b35a792	Available on FDA.report

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 104 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Cold Cough Product	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,	Unifirst First Aid Corporation	e8059137-efba-398c-e053-2a95a90a21f2	2025-09-08	Warnings	Exact identifier application number: M012
Medique Medi-Mucus	DEXTROMETHORPHAN HBR, GUAIFENESIN	Unifirst First Aid Corporation	f3bb862a-9cb8-f644-e053-2a95a90a5f4f	2025-09-08	Warnings	Exact identifier application number: M012
Physicians Care Cough and Sore Throat	MENTHOL	Acme United Corporation	4e02223d-f34b-333e-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application number: M012
Physicians Care Non-Drowsy Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Acme United	186ec543-1f23-75d6-e063-6294a90a46b9	2025-09-08	Warnings	Exact identifier application number: M012
PhysiciansCare Sinus Non-Drowsy	PHENYLEPHRINE HCL	Acme United Corporation	a6daf3ef-f386-4de4-b38e-d0b90c9ae62b	2025-09-08	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Multi-Symptom Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Acme United Corporation	fd101c27-6ba9-4cd3-baec-a354504c37a0	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Honey Lemon Cough Drop	MENTHOL 8.6 MG	Unifirst First Aid Corporation	8a94f090-61d6-4909-e053-2995a90aee38	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Cough Drop Relief	MENTHOL	Unifirst First Aid Corporation	0fc4cb11-8ff9-4eff-9588-c73eef4e0137	2025-09-08	Warnings	Exact identifier application number: M012
Multi-Symptom Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,	Unifirst First Aid Corporation	e6ea6faf-baff-a130-e053-2a95a90a085a	2025-09-08	Warnings	Exact identifier application number: M012
MEDIQUE Medikoff Drops	MENTHOL	Unifirst First Aid Corporation	0d6b4443-16a1-4851-bb03-d7407167551d	2025-09-08	Warnings	Exact identifier application number: M012
Medique Sugar Free Medikoff Drops	MENTHOL	Unifirst First Aid Corporation	92d13e19-4e7b-4565-970e-504abf02579a	2025-09-08	Warnings	Exact identifier application number: M012
Medique at Home Diphen	DIPHENHYDRAMINE HCL	Unifirst First Aid Corporation	b56d1966-efd7-56eb-e053-2995a90a89b5	2025-09-08	Warnings	Exact identifier application number: M012
Medique Chlorphen	CHLORPHENIRAMINE MALEATE	Unifirst First Aid Corporation	b3d5d161-8d4c-f1bb-e053-2a95a90a5bc5	2025-09-08	Warnings	Exact identifier application number: M012
Crane Safety Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Crane Safety LLC	968baa85-ce0e-0c3d-e053-2995a90ac03a	2025-09-08	Warnings	Exact identifier application number: M012
Thompson Cherry Cough Drops	MENTHOL	Thompson Safety LLC	c948f5b0-8491-6f9f-e053-2995a90a55fa	2025-09-08	Warnings	Exact identifier application number: M012
Medique Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e64c283b-0efa-0bfd-e053-2a95a90ab71d	2025-09-08	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	Walgreens	a99fdd49-0160-4a82-983b-fa56ab38ae76	2025-09-08	Warnings	Exact identifier application number: M012
Dye Free Wal Dryl Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	53e6f72d-15a4-4efe-8b1f-5753fed53df8	2025-09-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	40bfd631-51a4-4684-9ba0-a365d61da9bc	2025-09-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	f796ce1f-3077-4a0d-a41a-249c345ddb5f	2025-09-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42507-388-10	42507038810	1 BOTTLE, SPRAY in 1 CARTON (42507-388-10) / 30 mL in 1 BOTTLE, SPRAY (42507-388-30)	2002-05-13	No	No	Current